Safety and tolerability of DIM-based therapy designed as personalized approach to reverse prostatic intraepithelial neoplasia (PIN)

Background: It has been shown previously that novel formulation of 3,3'-diindolylmethane (DIM) substance with high bioavailability (Infemin) inhibits tumor development due to the tumor growth rate reduction in the xenograft model of prostate cancer. Prostatic intraepithelial neoplasia (PIN) is considered to be promising as a personalized and preventive treatment strategy of prostate cancer (PC). We assessed the safety of Infemin in men with PIN and discussed the interim results.Materials and methods: A total of 14 patients with PIN were enrolled. They were randomized to 900 mg DIM or placebo daily for 3 months. Safety was evaluated by adverse events (AEs), laboratory tests and physical examinations.Results and conclusion: The trial revealed that Infemin treatment is associated with minimal toxicity and no serious adverse events when administered orally for 3 months. We noted three adverse events including nausea and diarrhea in two patients (14%). Combined 95% confidence interval (CI) was 1.8%-42.8%. Therapy was continued in all cases of adverse events.Good tolerability of DIM-based formulation allows us to recommend it for further clinical trials among men diagnosed with PIN for its efficacy and long-term safety parameters. © 2014 Paltsev et al.

Authors
Paltsev M.1 , Kiselev V. 2 , Muyzhnek E.3 , Drukh V. 2 , Kuznetsov I.4 , Pchelintseva O. 2
Journal
Publisher
BioMed Central Ltd.
Number of issue
1
Language
English
Status
Published
Number
18
Volume
5
Year
2014
Organizations
  • 1 National Research Centre (NRC 'Kurchatov Institute'), 1, Akademika Kurchatova pl., Moscow, 123182, Russian Federation
  • 2 Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, Moscow, 117198, Russian Federation
  • 3 ZAO 'MiraxBioPharma', 12 Kutuzovsky av., Moscow, 121248, Russian Federation
  • 4 Moscow State Medical Stomatological University (MGMSU), Delegatskaya St. 2/1, Moscow, 127473, Russian Federation
Keywords
3,3'-Diindolylmethane; Bioavailability; Infemin; Molecularly targeted treatment; Personalized medicine; Preclinical trials; Prostate cancer; Prostatic intraepithelial neoplasia; Safety; Targeted prevention; Tolerability
Date of creation
19.10.2018
Date of change
19.10.2018
Short link
https://repository.rudn.ru/en/records/article/record/4825/